• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48005004S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a saber 5mm4cm 90 percutaneous angioplasty (pta) balloon catheter did not inflate during a pta shunt procedure. The device was replaced with a same size unknown balloon catheter to complete the procedure. No injury was reported to the patient. The device was delivered to the lesion, however pressure did not rise and the balloon did not inflate. The physician is unclear if there was an air leak from the catheter shaft or a balloon rupture. Additional information was requested but not provided. The device was returned for evaluation. Addendum: per product evaluation, results show the balloon leakage was caused by a rupture on the balloon surface.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSABER 5MM4CM 90
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key13841193
MDR Text Key291238821
Report Number9616099-2022-05470
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032068649
UDI-Public(01)20705032068649(17)230831(10)82202850
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48005004S
Device Catalogue Number48005004S
Device Lot Number82202850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
Treatment
UNK BALLOON CATHETER
-
-